Situation and Impacts on Previously Established Cosmetic Manufactures in Trang Province after Promulgation of the Notification on Criteria, Procedures, and Conditions for the Production or Import of Cosmetics B.E. 2561

Abstract

Background: The Ministry of Public Health promulgated the notification on criteria, procedures, and conditions for the productions and import of cosmetics B.E. 2561 (A.D. 2018) which effective since 24 May 2020. It affects cosmetic entrepreneurs who have been notified prior to the effective date of this notice who must comply with the notice within two years from the date.

Objectives: The study aimed to explore situation and impacts on previously established cosmetic manufacturers after promulgation of the notification.

Methods: This was a cross-sectional descriptive study between August 2019 and September 2020. It used the population of all cosmetic manufacturers in Trang province who applied for the notification on e-Submission system of the Thai Food and Drug Administration (FDA) by developed a cosmetic manufacturing database, evaluated production site standards and provided recommendation for improvement, and re-evaluated. Then, this research presented a frequency and percentage.

Results: The results found that there were a total of 33 cosmetic manufacturers in Trang province (data on 10 September 2019). It classified into 3 groups include: 12 manufacturers whose wish to continue their business at 12 places (36.37%) which later it remained 10 places because of close down two places, the group of 14 manufacturers that required going out of business (42.42%), and the group of seven non-contact manufacturing sites (21.21%). Then, when examining the manufactures in the group that need continue to operate 10 locations, it was discovered that the 6^th regulation category, the production operation, was a category where the cosmetics production facility had the highest failed evaluation results, such as no inspection of raw materials before and after taking, no labels showing raw material names and expiration dates, no method of assigning a number or letter at the time of manufacture, and no operation procedure in the packing process. Besides, when classifying the details of all reviewed topic by type of problem, it found that most of them had problems in preparing documents used in the production process, as well as recording details according to certain criteria due to lack of knowledge and awareness of quality control. Furthermore, the reasons for the cancellation of the business were found to be caused by (1) having hired of another entrepreneur to produce and notify cosmetics instead, (2) having impersonated address information by another person to apply for the notification numbers, (3) currently not producing but not applying for termination of the business, and (4) budget constraints.

Conclusions: One third cosmetic manufacturers was able to continue their business. During the audit period, there were the most problems in the manufacturing operation category. Therefore, we had a suggestion to promote the production of cosmetics as follows: (1) a government should issue stimulus policies and encourage manufacturers to earn more, (2) conduct practical training in quality control, preparation of documents and records in the production process, and study visit at manufacturers sites in other provinces that have better standards, and (3) improve consulting systems for new entrepreneurs through various communication channels.